Public Citizen Sues FDA Over Inaction That Allows Continued Pharmacy Compounding of Cesium Chloride

Public Citizen Also Petitions the FDA to Ban Dietary Supplements That Contain This Dangerous Chemical

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is endangering the public by allowing pharmacists and doctors to continue using cesium chloride to produce compounded medications promoted for treatment of cancer, Public Citizen said in a lawsuit (PDF) filed today against the agency.

FDA reviewers determined in 2016 that cesium chloride presents “serious safety concerns,” “is not safe for human use” and has not been shown to be effective for “the prevention or treatment of any form of cancer.” Still, the FDA left the chemical on a list of substances that it permits pharmacists and physicians to use in compounding without FDA approval or compliance with FDA requirements.

The suit, filed in the U.S. District Court for the District of Columbia, challenges the agency’s failure to act on a citizen petition (PDF) that Public Citizen submitted to the FDA in December 2017 asking the agency to move cesium chloride off the permissive list and to issue a rule that prohibits pharmacy compounding of cesium chloride medications.

In June 2018, the agency stated in a letter (PDF) to Public Citizen that it had not reached a decision on the petition. Public Citizen’s lawsuit explains that the FDA has unlawfully withheld a decision on the petition and has been provided sufficient evidence of the dangers of the chemical to make a determination.

Also today, Public Citizen petitioned (PDF) the FDA to ban dietary supplements that contain cesium chloride and provide safety communications to consumers and doctors about the dangers of such supplements.

A growing body of evidence has shown cesium chloride and other cesium salts cause serious, life-threatening cardiovascular events, including cardiac arrest, when taken in amounts recommended or suggested in product labeling.

“It is incomprehensible that the FDA has not yet taken action to prevent pharmacy compounding of cesium chloride and ban the marketing of cesium-containing dietary supplements,” said Meena Aladdin, health researcher in Public Citizen’s Health Research Group. “The failure to act exposes patients and other consumers to dangerous, ineffective compounded medications and dietary supplements that can cause life-threatening harm.”